[国家卫生科学研究所醋酸泼尼松龙参比标准(Control 941)]。

A Kitajima, K Maekawa, K Yoshii, H Komatsu, T Tanimoto
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引用次数: 0

摘要

为编制《醋酸泼尼松龙参比标准品(Control 941)》,对醋酸泼尼松龙的原料进行了检测。得到的分析数据如下:熔点237.5℃(分解);紫外、红外光谱与JP醋酸泼尼松龙参比品(对照品903)相同;λ max比吸光度E1%1cm = 379;旋光度,[α]20D = +115.2度;薄层色谱法和高效液相色谱法,均未检出杂质;高效液相色谱法测定,100.8%。根据上述结果,该候选物质被批准为日本药典参考标准(Control 941)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
[Prednisolone acetate reference standard (Control 941) of the National Institute of Health Sciences].

The raw material for prednisolone acetate was tested for preparation of the "Prednisolone Acetate Reference Standard (Control 941)". Analytical data obtained were as follows: melting point, 237.5 degrees C (decomposition); UV and infrared spectra, the same as those for JP Prednisolone Acetate Reference Standard (Control 903), respectively; specific absorbance at lambda max E1%1cm = 379; optical rotation, [alpha]20D = +115.2 degrees; thin-layer chromatography and high-performance liquid chromatography (HPLC), no impurities were detected, respectively; assay, 100.8% by HPLC. Based on the above results, the candidate material was authorized as the Japanese Pharmacopoeia Reference Standard (Control 941).

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